Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)
|ClinicalTrials.gov Identifier: NCT01720823|
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : April 5, 2016
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.
Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
|Condition or disease||Intervention/treatment|
|Sleep Apnea, Obstructive||Device: home polysomnography (GETEMED) Device: standard polysomnography (BRAINNET II)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study|
|Study Start Date :||October 2012|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
Experimental: home polysomnography and standard polysomnography
home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night.
Device: home polysomnography (GETEMED)
Other Name: GETEMEDDevice: standard polysomnography (BRAINNET II)
Other Name: BRAINNET II
- Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. [ Time Frame: 1 night ]
- Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) > 5 / hr.
Home polysomnography considered pathological if at least one of the following criteria is present :
- Respiratory Disturbance Index (RDI) > 10 / hr + /- Desaturation Index > 4% for more than 2.5 / hr.
- Brouillette index ; pulse wave > 3 desaturation clusters and > 3 desaturation <90%.
- To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography. [ Time Frame: 1 night ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720823
|Hospices Civils de Lyon- Hôpital Femme Mère Enfant|
|Bron, France, 69677|
|Principal Investigator:||Patricia FRANCO, MD||Hospices Civils de Lyon- Hôpital Femme Mère Enfant|